The 35-year-old 510(k) process is for lower risk, Class II medical devices, which resemble other devices currently on the market. The category includes most diagnostic imaging equipment.

About 3,000 devices are cleared through this process every year, Shuren said.


But the program has come under fire from patient and safety advocates who say it doesn't do enough to screen out faulty or dangerous devices.

In fact, the current changes partly stem from controversy surrounding a collagen knee implant called Menaflex, made by ReGen Biologics Inc., which was cleared more than two years ago.

A 2009 FDA internal review said the agency experienced "unprecedented" outside pressure, including from members of Congress, to clear the device, even though the agency later said it did not meet 510(k) criteria. In October, FDA rescinded clearance for the product.

To review the 510(k) process, the FDA assembled two internal workgroups, held two public workshops and solicited more than 76 written comments from manufacturers, providers and the public.

Last summer, as a result of the reviews, the agency initially proposed around 55 changes to the 510(k) process.

Of the 25 actions the FDA is working on now, some could start wheezing into bureaucratic life this spring. The agency said it would post a charter for the new scientific council on its website by the end of March.

And in September, the agency said it would issue draft guidance on reforms to the "de novo" process. This is a process to prevent Class III designation, which usually requires expensive clinical trials, for devices that don't resemble anything currently on the market but which are deemed low risk.

Wednesday's changes were hinted at Tuesday by President Obama in an op-ed piece in the Wall Street Journal in which the president announced an executive order that calls for a government-wide review of federal regulations that could stifle U.S. competitiveness. The president also extolled a "21-st century regulatory system" that struck a balance between oversight and economic growth.

"[O]ne of the reasons the free market has worked is that we have sought the proper balance," he wrote. "We have preserved freedom of commerce while applying those rules and regulations necessary to protect the public against threats to our health and safety and to safeguard people and businesses from abuse."

By May, federal agencies will have to submit a preliminary plan to the Office of Information and Regulatory Affairs about whether any rules should be streamlined or cut, according to Federal News Radio.

Read the FDA's plan of action here: http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM239450.pdf

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